Patient preference to guide AFO prescription

Rationale: The majority of neurological patients with impaired gait can be prescribed with a carbon off-the-shelf ankle-foot orthoses (AFO) to improve their walking ability. A variety of these off-the-shelf AFOs is available on the market, claiming to store and release energy to enhance ankle push-off power. Clinical data on their effectiveness is however scarce, as well as clear criteria to support the prescription process. Yet, it is unclear for orthotists which AFO to choose for a specific patient. Consequently, the prescription process is ambiguous and choice for a specific AFO is often based on personal preference, knowledge of available products, clinical experience, and/or the patient’s preference. Although the patient’s preference has been measured before, it is unclear whether patients are able to choose the AFO that is most effective improving their walking ability. Hence, it is unknown whether an orthotist and/or physician can rely on the patient’s own experience within their decision-making process.
Objective: To investigate whether the patient’s preference during AFO-fitting could be guiding in the decision-making process of off-the-shelf carbon AFO prescription.
Study design: Explorative cross-sectional intervention study.
Study population: Neurological patients with reduced ankle push-off power using an off-the-shelf carbon AFO.
Intervention (if applicable): All patients receive two AFOs during AFO fitting. In the following 4 weeks, they use the two AFOs at home. In the first week they will use AFOa, in the second week AFOb and in weeks 3 and 4 the AFO of their own preference (which can vary day by day).
Main study parameters/endpoints: The primary outcome measure is % agreement between patient’s preference and AFO efficacy in terms of L-test performance.

It is expected that patients prefer the AFO with the best efficacy, and that the preference is reliable at the moment of AFO fitting.

At baseline (T0), patients will perform a L-test with both AFOs, and their preference will be assessed. Afterwards, patients are sent home with both AFOs, and will be instructed to wear each AFO consecutively for one week (T1-AFOa and T1-AFOb – randomized order). After these two weeks, patients are allowed to wear the AFO according to their own preference for another two weeks (T1-AFOp). Within this period, patients are allowed to switch AFOs whenever they want. During T1, treatment adherence will be measured with a micro temperature sensor. After four weeks of wearing the AFOs, patients return to the Sint Maartenskliniek for final evaluation measurements, consisting of an L-test and 3D gait analysis during a 2-minute walk test (2MWT) and precision stepping task (PST) to assess AFO efficacy. Additionally, patient’s preference will be assessed

Two off-the-shelf carbon AFOs: i) Toe-OFF (AllardInt, Helsingborg, Sweden) and ii) Sprystep Max (Thuasne, Levallois-Perret, France).